MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036123090
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil was unable to be detached by the power supply and after three attempts, the physician tried to remove the subject coil from the micro catheter, but the coil got stuck inside the micro catheter.The physician then retrieved the subject coil along with the micro catheter and the coil was found prematurely detached inside the micro catheter.The procedure was completed successfully and there were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H3 device evaluated by mfg - updated.H3 summary attached - updated.H4 manufacturing date ¿ added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned.However, the lot number was not confirmed as the packaging was not returned with the device.Visual analysis indicated that the coil delivery wire was kinked/bent and the main coil appeared to be electrolytically detached.Functional analysis was not required as the main coil was returned detached.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The coil was found prematurely detached during analysis.It is most likely that anatomical or procedural factors resulted the coil jammed and eventually detached when trying to remove.The event appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.Therefore, an assignable cause of procedural factors was assigned to the reported event.
Event or Problem Description
It was reported that the subject coil was unable to be detached by the power supply and after three attempts, the physician tried to remove the subject coil from the micro catheter, but the coil got stuck inside the micro catheter.The physician then retrieved the subject coil along with the micro catheter and the coil was found prematurely detached inside the micro catheter.The procedure was completed successfully and there were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9406908
• Report Number: 3008881809-2019-00372
• Device Sequence Number: 2167527
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: 07613327128284
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2021
• Device Model Number: M0036123090
• Device Catalogue Number: M0036123090
• Device Lot Number: 20968848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LANTERN MICROCATHETER (PENUMBRA)